Novel Post-surgical Incision Management Device to Prevent Ostomy Complications

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Project Summary/Abstract Over 100,000 patients of all ages undergo ostomy surgery in the United States (US) annually due to a variety of pathophysiologic conditions including colorectal cancer, inflammatory bowel disease (Crohn’s disease and ulcerative colitis), bowel obstruction, diverticulitis, and many other medical conditions. Ostomy surgery may also be necessary in cases of severe abdominal or pelvic trauma resulting from accidents or from injuries sustained during military service. A life-saving procedure, ostomy surgery allows bodily waste to pass through a surgically created opening called a stoma on the abdomen into a prosthetic known as a ‘pouch’ or ‘ostomy bag’ on the outside of the body. Patients are discharged from the hospital within days of ostomy creation and expected to heal at home using disposable ostomy pouches attached to the skin around their stoma. Unfortunately, current pouch designs offer little therapeutic benefit for post-surgery edema (swelling) and may not maintain a tight seal, allowing leakage of intestinal fluid and waste. Resulting stoma complications include mucocutaneous (skin/stoma) separation, stoma retraction, and moisture-associated skin damage. Up to 70% of ostomy patients endure these complications, with 29% of these patients requiring hospital readmissions at an additional cost of $78,000 per patient. Furthermore, risks for complications are higher for high body mass index (BMI) patients. Given the rise in clinical conditions requiring ostomy surgery, the increased BMI of the US population, and the current reimbursement landscape that penalizes the healthcare system for readmissions, an improved post- surgical incision management device to prevent ostomy complications is urgently needed. In this SBIR Direct Phase II, Fistula Solution will develop a novel post-surgical ostomy incision management device designed to prevent complications, form a tight seal, and protect the new stoma. This device stabilizes the tissue around the stoma to reduce edema and tension on sutures, along with holding the skin/stoma junction together to facilitate healing. In addition, the device creates a secure seal to stop stool leaks and prevent MASD. Our specific aims are to 1) optimize product design for manufacturability and clinical benefits; 2) verify product design and biocompatibility; and 3) conduct a clinical trial comparing the device to conventional adhesive ostomy pouches with HealthPartners Institute and Regions Hospital in St. Paul, Minnesota. The successful execution of our specific aims will establish device safety and efficacy and ensure the device is designed for manufacturability and biocompatibility. The human health benefit is a new standard of care to improve ostomy patient outcomes, shorten hospital stays, reduce readmissions to hospital, and mitigate a major financial exposure for hospitals.